argenex (NASDAQ:ARGX) reported what executives described as one of its strongest quarters to date, driven by continued growth for VYVGART across myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, as well as early momentum from a newly expanded label in generalized myasthenia gravis.
On the company’s second-quarter 2026 earnings call, Chief Executive Officer Karen Massey said argenx delivered its 18th consecutive quarter of growth and is advancing toward its Vision 2030 plan, which includes a goal of reaching 10 labeled indications and advancing five late-stage molecules by 2030.
Product Sales Rise 60% Year Over Year
Chief Financial Officer Karl Gubitz said product net sales were $1.5 billion in the second quarter, up 60% from the prior year and 17% from the first quarter. U.S. product net sales totaled $1.3 billion, while Japan contributed $102 million, the rest of the world contributed $136 million, and product supply to Zai Lab in China accounted for $5 million.
Gubitz said U.S. market growth was 15% quarter over quarter, with gross-to-net and net pricing similar to prior quarters. In Japan, net product sales increased 55% sequentially, or $35 million, though reported sales included a one-time benefit of about $25 million tied to a distribution model change.
Total operating expenses were $1 billion in the quarter, up $129 million from the first quarter. Combined research and development and selling, general and administrative expenses were $903 million, which Gubitz said reflected “disciplined investment” in clinical development and commercial capabilities. Operating profit was $494 million, up 146% year over year. The company ended the quarter with $5.2 billion in cash, cash equivalents and current financial assets, an increase of more than $744 million from the start of the year.
VYVGART Momentum Continues in MG and CIDP
Chief Commercialization Officer Sandrine Piret-Gerard said VYVGART growth continued across both MG and CIDP and across all regions, with new patient demand remaining consistently high. She said the prefilled syringe has been an important driver of demand, with about 80% of U.S. prefilled syringe patients in the second quarter new to VYVGART.
Piret-Gerard said the company now has a repeat prescriber base of more than 5,000 neurologists and is seeing increased use earlier in the treatment journey. In response to a question, she clarified that the 80% figure referred specifically to the second quarter, while the launch-to-date figure for prefilled syringe patients new to VYVGART was about 70%.
Executives also highlighted the recent approval of VYVGART for seronegative generalized myasthenia gravis. Massey said the drug is now the first and only treatment approved across all serotypes of generalized MG, including triple seronegative patients. Piret-Gerard said the label expansion increases the addressable MG market by 11,000 patients and has generated positive feedback from patients and physicians.
On payer coverage, Piret-Gerard said policies now cover about 55% of U.S. commercial lives within 10 weeks of launch, and most plans are removing serology testing requirements. She said the expanded label is also having a “halo effect” on broader gMG prescribing, including in seropositive patients.
CIDP Expansion Remains a Focus
In CIDP, Piret-Gerard said argenx is working to expand beyond its initial 12,000-patient addressable population in the United States. She said about 24,000 U.S. patients are being treated for CIDP, with roughly half considered well managed on existing therapy, though the company believes many patients have adapted their lives around lost function.
The company cited data from a phase 4 switch study presented at the Peripheral Nerve Society meeting showing that 87% of patients on IVIG switched successfully to VYVGART. Piret-Gerard also pointed to data presented at the American Academy of Neurology showing that 87.5% of treatment-naive CIDP patients benefited from a clinical response.
She said VYVGART use in treatment-naive patients remains a developing opportunity, but adoption takes time because many physicians start patients on IVIG and many payers still require some IVIG experience.
Pipeline Readouts Expected Before Year-End
Massey said argenx has two registrational readouts expected before the end of 2026: VYVGART in autoimmune myositis and empasiprubart in multifocal motor neuropathy, or MMN.
For autoimmune myositis, Massey said the company is on track for a third-quarter readout and is evaluating both immune-mediated necrotizing myopathy, or IMNM, and dermatomyositis, or DM. She said there are no approved treatments today for IMNM and that argenx has breakthrough designation from the FDA in that subtype.
Chief Medical Officer Luc Truyen, who joined for the question-and-answer session, said the company will analyze the IMNM and DM subsets independently. Massey said success would be a positive readout on the primary endpoint in one or more subsets, and that both IMNM and DM could represent potential blockbuster indications on their own.
For empasiprubart, Massey said the first registrational readout in MMN is expected later this year. Truyen said the phase 3 trial compares empasiprubart head to head against IVIG after patients are stabilized on IVIG, with grip strength as the endpoint. Massey said success would be a positive readout on the primary endpoint of non-inferiority, with superiority representing upside.
Company Sees Broader Immunology Opportunity
Massey said argenx is also advancing additional pipeline candidates, including next-generation FcRn molecules ARGX-213 and ARGX-124, the IgA “sweeper” ARGX-121, and earlier-stage programs ARGX-118, ARGX-125 and TSP-101. She said ARGX-213 is “phase III-ready,” while ARGX-124 is in phase 1 and could be positioned for late-stage development by year-end.
Discussing ARGX-121, Massey said phase 1 data showed about a 90% reduction in IgA within days, maintained through day 28 after a single dose. Truyen said key opinion leaders had responded enthusiastically to the depth and speed of IgA reduction as the company moves into IgA nephropathy.
On business development, Massey said the company’s capital allocation strategy remains focused on fueling VYVGART growth, advancing the internal pipeline and using the strength of the balance sheet to pursue external opportunities. She said argenx is focused on immunology assets with novel biology and significant unmet patient need, while seeking to diversify beyond FcRn.
“We hold the bar high,” Massey said, “but I can tell you when we find those opportunities where we can have an impact for patients, we will leverage the flexibility of the balance sheet to be able to go after them.”
About argenex (NASDAQ:ARGX)
argenx (NASDAQ: ARGX) is a biotechnology company focused on the discovery, development and commercialization of antibody-based therapeutics for severe autoimmune and neuromuscular diseases. The company uses its proprietary SIMPLE Antibody platform to generate differentiated antibodies and engineered Fc regions, and it pursues mechanisms that modulate the neonatal Fc receptor (FcRn) to reduce pathogenic IgG levels. Argenx’s research and development activities span target identification, preclinical development and late-stage clinical programs aimed at addressing unmet needs in immunology.
The company’s lead product, efgartigimod (marketed as Vyvgart), is an FcRn antagonist developed to reduce circulating IgG antibodies and treat IgG-mediated disorders.
